A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease (SIBERITE-PEDS)

Roche

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Moderately to Severely Active Crohns Disease

Treatments: Drug: Afimkibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT07298421

CP45906

2025-523318-96-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body weight >= 10 kilogram (kg)
• Active CD confirmed by endoscopy (ileocolonoscopy)
• Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score >= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) >=6 (or >=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy
• Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)

Exclusion criteria

• Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
• History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
• Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.
• Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
• Presence of abdominal or perianal abscess
• Current diagnosis or suspicion of primary sclerosing cholangitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Afimkibart Dose A

Experimental group

Description:

Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.

Treatment:

Drug: Afimkibart

Afimkibart Dose B

Experimental group

Description:

Participants will receive Afimkibart IV followed by Afimkibart SC.

Treatment:

Drug: Afimkibart